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Nutrition and Cognitive Function in Preadolescents

Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02636998
Collaborator
(none)
116
Enrollment
1
Location
99
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate cognitive function in preadolescents who have different body mass indexes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators plan to document differences between normal weight and obese preadolescents on psychological and neurocognitive measures of executive function controlling for factors known to influence brain function and behavior not considered in previous studies.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    116 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Nutrition and Cognitive Function in Preadolescents
    Actual Study Start Date :
    Jun 1, 2015
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Normal weight

    BMI <85th percentile
    Obese

    BMI > 95th percentile

    Outcome Measures

    Primary Outcome Measures

    1. Psychological assessments [9-10 years]

      Standardized assessments

    2. Neurocognitive measures [9-10 years]

      Brain Lab Recordings

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Normal weight (BMI: <85th percentile) or obese (BMI: >95th percentile)

    • Right hand dominance

    • Report eating breakfast at least 4 days/week

    • Able to hear at least 20 dB stimulus

    • Visual acuity must be at least 20/40

    • Arithmetic Computation Task

    • Biological mother available to attend the enrollment study visit

    Exclusion Criteria:

    • Full Scale IQ <80

    • Children taking medications or having chronic illnesses/disorders that may independently affect study outcome measures (as determined by the PI)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Children's Nutrition Center Little Rock Arkansas United States 72202

    Sponsors and Collaborators

    • Arkansas Children's Hospital Research Institute

    Investigators

    • Principal Investigator: Linda Larson-Prior, Ph.D, Arkansas Children's Nutrition Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arkansas Children's Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT02636998
    Other Study ID Numbers:
    • 204071
    First Posted:
    Dec 22, 2015
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    No Results Posted as of Aug 5, 2022